Ratiopharm Selects TrackWise software as its Enterprise Quality and Compliance Management System
Holmdel, NJ – May 30, 2007 – Sparta Systems, Inc. (Sparta). the maker of TrackWise® and the market leader in enterprise quality and compliance management software, today announced that ratiopharm GmbH (ratiopharm), a leading international generics producer, has selected TrackWise as its enterprise tool for managing deviations, corrective and preventive actions (CAPA) and audits.
TrackWise is a web-based tracking software tool for electronically managing, tracking, and trending quality, regulatory, and organizational compliance processes and action items across the enterprise. TrackWise increases efficiency and ensures compliance by integrating data and processes into a centralized system, automating workflow, facilitating trending and reporting, and executing business rules.
ratiopharm’s global growth and quality initiatives led the company to evaluate enterprise quality management software systems to replace siloed databases and paper-based forms. The company envisioned a powerful system that would eliminate errors, speed cycle time, increase record transparency, and reduce associated operational costs. TrackWise was selected based on its features, flexibility, rapid implementation time, and Sparta Systems’ recognized best practices in the life sciences industry.
ratiopharm will phase out its databases and manual processes and automate them with TrackWise. The TrackWise system will streamline the company’s deviations, CAPA, and audit management processes with an automated workflow engine, patented business rules engine, built-in workflow tools, integrated reporting and trending, and automated escalation features. The initial implementation will encompass the ratiopharm production sites, and is slated for 2007 completion, with systematic expansion planned for other groups.
“Managing multiple quality-related processes with disjointed office applications limits you in terms of data availability, data safety, accurate trending, and transparency of information,” explained Britta Rotte, QA Manager, ratiopharm. “TrackWise will facilitate the needs of our corporate QA system by centralizing QA processes and providing the data needed for tracking and trending quality issues to support improvement initiatives. Furthermore, the extensive configurability of TrackWise will allow us to create detailed processes without touching the source code of the system, reducing validation and revalidation effort.”
“Selecting an electronic quality and compliance management system that is easily adaptable to business and regulatory change is critical for life science companies,” explained Yaniv Vardi, Vice President, Operations, Sparta Systems Europe, Ltd. “TrackWise’s ability to manage unlimited workflows on a centralized, vendor-neutral platform will enable ratiopharm to meet its current and future compliance needs seamlessly without changes to code or the installation of additional modules, which will provide a significant return on investment.”
Subsequent planning for further QA processes at ratiopharm includes change control, validation, qualification, and SOP management.
About ratiopharm GmbH
Founded in 1974, ratiopharm GmbH is a leading international generics producer. In addition to its headquarters in Germany, ratiopharm is represented worldwide with branches in 24 countries. With about 750 medicines, ratiopharm has one of the widest product ranges in the industry, meeting the needs of virtually all areas of medicine, from allergies to circulation problems and from gastroenteritis to toothaches. More information is available at www.ratiopharm.com.
About Sparta Systems
Sparta Systems, Inc. is the industry leader for enterprise process management solutions. Its product, TrackWise, is used by over 200 companies to ensure compliance, improve control, reduce risk, and lower costs by consolidating management of issues and actions, automating workflow, and facilitating trending and reporting. Sparta Systems offers more than 12 years of experience. Additional information about Sparta Systems and TrackWise® can be found at www.sparta-systems.com.
